Bittner Ava K, Seger Kenneth
Nova Southeastern University, College of Optometry, 3200 S. University Drive, Fort Lauderdale, FL, 33328, USA.
Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):299-306. doi: 10.1007/s00417-017-3858-8. Epub 2017 Dec 8.
A small-scale randomized controlled trial conducted by our group found that four of seven retinitis pigmentosa (RP) subjects who received six weekly Transcorneal Electrical Stimulation (TES) sessions developed significant improvements in visual acuity (VA), quick contrast sensitivity function (qCSF), and/or Goldmann visual fields (GVF). We longitudinally monitored three of these participants for declining visual function due to natural RP progression to determine the duration of their responses and administered retreatments.
Over a period of 29-35 months, repeated ETDRS VA, qCSF and/or GVF tests and three to six TES treatment courses consisting of six weekly sessions were administered in each eye of three RP participants every four to 16 months in an unmasked, prospective case series study.
For two participants, there were significant VA improvements of 44-52 letters (0.88-1.04 logMAR) and 15-23 letters (0.3-0.46 logMAR) in the worse eye at baseline after each of three or four treatment courses of TES compared to initial baseline. They had no significant decreases from baseline for VA or qCSF over 29 to 35 months, The third participant had a significant mean improvement in VA in the eye with better baseline vision (p = 0.004) and binocularly (p < 0.001) following six treatment courses over the 29-month period. For the first two participants, mean annual rates of GVF change for each eye ranged from -5% to 0% with the V4e stimulus, and -26% to +33% the III4e stimulus. The third participant's mean annual GVF changes were +14 to +35%, with a statistically significant improvement across 29 months for both the V4e and III4e stimuli in the right eye (p = 0.045; p = 0.015) and the V4e stimulus in the left eye (p = 0.047).
Following encouraging visual improvements after TES that lasted for several months, it appears it may be possible to restore and prevent slowly diminishing vision over time with retreatments, which requires confirmation in a large-scale randomized controlled trial.
我们小组进行的一项小规模随机对照试验发现,7名接受每周6次经角膜电刺激(TES)治疗的视网膜色素变性(RP)患者中有4名在视力(VA)、快速对比敏感度函数(qCSF)和/或Goldmann视野(GVF)方面有显著改善。我们对其中3名参与者进行了纵向监测,以观察由于RP自然进展导致的视力下降情况,从而确定他们的反应持续时间并进行再次治疗。
在一项非盲法前瞻性病例系列研究中,在29至35个月的时间里,每4至16个月对3名RP参与者的每只眼睛进行重复的ETDRS视力、qCSF和/或GVF测试,并给予由每周6次治疗组成的3至6个TES治疗疗程。
对于两名参与者,在进行3或4个疗程的TES治疗后,与初始基线相比,较差眼睛的视力在基线时分别有44 - 52个字母(0.88 - 1.04 logMAR)和15 - 23个字母(0.3 - 0.46 logMAR)的显著改善。在29至35个月期间,他们的视力或qCSF与基线相比没有显著下降。第三名参与者在29个月内接受6个疗程治疗后,基线视力较好的眼睛以及双眼的视力均有显著的平均改善(p = 0.004)和(p < 0.001)。对于前两名参与者,每只眼睛使用V4e刺激时GVF的年平均变化率在 - 5%至0%之间,使用III4e刺激时在 - 26%至 + 33%之间。第三名参与者的GVF年平均变化为 + 14%至 + 35%,右眼在29个月内使用V4e和III4e刺激均有统计学显著改善(p = 0.045;p = 0.015),左眼使用V4e刺激时有显著改善(p = 0.047)。
在TES治疗后出现持续数月的令人鼓舞的视力改善后,似乎通过再次治疗有可能随着时间的推移恢复并防止视力缓慢下降,这需要在大规模随机对照试验中得到证实。